Plusvent 25 micrograms/125 micrograms/inhalation, suspension for inhalation pressurised container

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Plusvent 25 micrograms/125 micrograms/inhalation, suspension for inhalation in pressurised container

salmeterol/fluticasone propionate

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Plusvent is and what it is used for
2. What you need to know before using Plusvent
3. How to use Plusvent
4. Possible side effects
5. How to store Plusvent
6. Contents of the pack and other information

1. What Plusvent is and what it is used for

Plusvent contains two active substances, salmeterol and fluticasone propionate:

• Salmeterol is a long-acting bronchodilator. Bronchodilators help keep the airways in the lungs open, making it easier to breathe in and out. The effects last for at least 12 hours.
• Fluticasone propionate is a corticosteroid that reduces inflammation and irritation in the lungs.

Your doctor has prescribed this medicine to help prevent breathing problems such as asthma.

You should use Plusvent every day as directed by your doctor. This will ensure the medication works properly to control your asthma.

Plusvent helps prevent shortness of breath and wheezing. However, Plusvent must not be used to relieve a sudden attack of breathlessness or wheezing. In such cases, you must use your "rescue" medication with fast action, such as salbutamol. You should always carry your fast-acting rescue medication with you.

2. What you need to know before using Plusvent

Do not use Plusvent

• if you are allergic to salmeterol, fluticasone propionate, or any of the other ingredients, norflurane (HFA 134a).

Warnings and precautions

Talk to your doctor before starting to use Plusvent if you have:

• Heart problems, including rapid or irregular heartbeat.
• Hyperthyroidism.
• High blood pressure.
• Diabetes mellitus (Plusvent may increase blood sugar levels).
• Low levels of potassium in the blood.
• Current or past tuberculosis (TB) or other lung infections.

Contact your doctor if you experience blurred vision or other visual disturbances.

Other medicines and Plusvent

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including medicines for asthma or those obtained without a prescription. This is because, in some cases, Plusvent should not be administered together with certain other medicines.

Inform your doctor if you are taking any of the following medicines before starting to use Plusvent:

• β-blockers (such as atenolol, propranolol, and sotalol). β-blockers are mostly used to treat high blood pressure or other heart conditions.
• Medicines to treat infections (such as ketoconazole, itraconazole, and erythromycin), including some medicines for HIV (such as ritonavir, cobicistat). Some of these medicines may increase the amount of fluticasone propionate or salmeterol in your body. This may increase your risk of adverse effects with Plusvent, including irregular heartbeats, or may worsen side effects. Therefore, your doctor may monitor you closely if you are taking these medicines.
• Corticosteroids (oral or injectable). If you have recently taken these medicines, there may be an increased risk that this medicine will affect your adrenal gland.
• Diuretics, also known as "water pills," used to treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Medicines containing xanthines. These are often used to treat asthma.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Plusvent is unlikely to affect your ability to drive or operate machinery.

3. How to use Plusvent

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• Use Plusvent every day until your doctor tells you to stop. Do not take more than the recommended dose. If in doubt, consult your doctor or pharmacist.
• Do not stop taking Plusvent or reduce your dose without first talking to your doctor.
• Plusvent must be inhaled through the mouth into the lungs.

Adults and adolescents aged 12 years and older

• Plusvent 25/50 micrograms: 2 actuations twice daily
• Plusvent 25/125 micrograms: 2 actuations twice daily
• Plusvent 25/250 micrograms: 2 actuations twice daily

Children aged 4 to 12 years

• Plusvent 25/50 micrograms: 2 actuations twice daily

Plusvent is not recommended for use in children under 4 years of age.

Your symptoms may become well controlled by using Plusvent twice daily. If so, your doctor may decide to reduce your dose to once daily. The dose may be changed to:

• once at night if you have nocturnal symptoms,
• once in the morning if you have diurnal symptoms.

It is very important that you follow your doctor's instructions on how many actuations to take and how often.

If you are using Plusvent to treat asthma, your doctor will want to monitor your symptoms regularly. If your asthma worsens or you have increasing difficulty breathing, see your doctor immediately. You may notice more wheezing, a greater sensation of breathlessness, or that you need to use your "rescue" fast-acting medication more frequently. If any of these occur, continue using Plusvent, but do not increase the number of actuations. Your respiratory condition may worsen and you may become seriously ill. See your doctor, as you may need additional treatment.

Instructions for use

• Your doctor, nurse, or pharmacist should show you how to use your inhaler. They should periodically check your inhaler technique. Not using the Plusvent inhaler correctly or as prescribed may result in your asthma not improving as it should.
• The medicine is contained in a pressurized cartridge inside a plastic casing with a mouthpiece.
• The inhaler has a counter on the back indicating how many actuations remain. Each time you actuate the inhaler, one dose is released and the counter decreases by one unit.
• Be careful not to drop the inhaler, as this may cause the counter to decrease by one unit.

Checking the inhaler

1. If you are using your inhaler for the first time, check that it works properly. Remove the mouthpiece protector by gently pressing the sides with your thumb and index finger and pulling it off.

1. To ensure it works, shake the inhaler well, point the mouthpiece away from you, and press down on the cartridge to release one actuation into the air. Repeat these steps—shaking the inhaler before releasing each actuation—until the dose counter reads 120. If you have not used your inhaler for one week or longer, release two actuations of the medicine into the air.

Using the inhaler

It is important to begin inhaling as slowly as possible just before using your inhaler.

1. It is recommended that you stand or sit upright while using the inhaler.
2. Remove the mouthpiece protector (as shown in the figure). Check inside and outside that the mouthpiece is clean and free of foreign particles.
3. Shake the inhaler 4 or 5 times to ensure any foreign particles are removed and the contents of the inhaler are properly mixed.

1. Hold the inhaler in an upright position with your thumb on the base of the inhaler, below the mouthpiece. Breathe out as much air as possible.

1. Place the mouthpiece in your mouth, between your teeth. Close your lips around the mouthpiece. Do not bite it.

1. Breathe in slowly and deeply through your mouth. Immediately after starting to inhale, press down firmly on the top of the inhaler to release the medicine. Do this while continuing to inhale deeply and steadily.

1. Hold your breath, remove the inhaler from your mouth, and remove your finger from the top of the inhaler. Continue holding your breath for as long as possible.

1. Wait approximately 30 seconds between each actuation of the medicine, then repeat steps 3 to 7.

2. Afterwards, rinse your mouth with water, spit it out, and/or brush your teeth. This will help prevent mouth ulcers and hoarseness.

3. After use, always replace the mouthpiece protector immediately to protect it from dust. When the mouthpiece protector is correctly in place, it will make a "click" sound. If it does not click, rotate the mouthpiece protector, turn it over, and try again. Do not use excessive force.

Take your time with steps 4, 5, 6, and 7. It is important that you breathe out as slowly as possible just before using the inhaler. The first few times you use the inhaler, you should use it in front of a mirror. If you see a "mist" coming from the top of the inhaler or from the sides of your mouth, start again from step 3.

As with all inhalers, caregivers must ensure that children using the Plusvent Inhaler use the correct inhalation technique described above.

If you or your child find it difficult to use the inhaler, your doctor, nurse, or other healthcare professional may recommend using the inhaler with a Volumatic spacer device. Your doctor, nurse, pharmacist, or other healthcare professional should show you how to use the spacer device with your inhaler, how to maintain your spacer device, and answer any questions you may have. If you are using a spacer device with your inhaler, it is important not to stop using it without first consulting your doctor or nurse. It is also important not to change the type of spacer device you are using without consulting your doctor. If you stop using the spacer device or change the type of spacer device, your doctor may need to adjust the dose of medicine required to control your asthma. Always consult your doctor before making any changes to your asthma treatment.

Some children or people with weak hand strength may find it easier to hold the inhaler with both hands. Place both index fingers on the top of the inhaler and both thumbs on the base, below the mouthpiece.

You should obtain a replacement inhaler when the counter reads 020. Stop using the inhaler when the counter reads 000, as the remaining doses in the cartridge may not be sufficient to deliver a full dose. Never attempt to alter the counter display or remove the counter from the metal cartridge.

Cleaning the inhaler

To prevent blockage of your inhaler, it is important to clean it at least once a week.

To clean your inhaler:

• Remove the mouthpiece protector.
• Never remove the metal cartridge from the plastic casing at any time.
• Clean the inside and outside of the mouthpiece and the plastic casing with a dry tissue.
• Replace the mouthpiece protector. It will make a "click" when correctly in place. If it does not click, rotate the mouthpiece protector, turn it over, and try again. Do not use excessive force.

Do not immerse the metal cartridge in water.

If you use more Plusvent than you should

It is very important to use the inhaler as directed. If you accidentally take a higher dose than recommended, consult your doctor or pharmacist. You may notice your heart beating faster than normal and feel tremors. You may also experience headache, dizziness, muscle weakness, and joint pain.

If you have used large doses over long periods of time, you should seek advice from your doctor or pharmacist. This is because high concentrations of Plusvent may reduce the amount of steroid hormones produced by the adrenal gland.

In case of overdose, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to use Plusvent

Do not take a double dose to make up for a missed dose. Take the next dose at your usual time.

If you stop treatment with Plusvent

It is very important that you use Plusvent every day as directed. Continue taking it until your doctor tells you to stop. Do not stop treatment abruptly with Plusvent, as this could cause your breathing to worsen.

In addition, if you stop taking Plusvent suddenly or reduce your dose, you may (very rarely) develop problems with your adrenal gland (adrenal insufficiency), which sometimes causes adverse effects.

These adverse effects may include any of the following:

• Stomach pain.
• Tiredness and loss of appetite, feeling unwell.
• Malaise and diarrhea.
• Weight loss.
• Headache or drowsiness.
• Low blood sugar levels.
• Hypotension and seizures (fits).

When your body is under stress, such as fever, trauma (e.g., traffic accident), infection, or surgery, adrenal insufficiency may worsen and you may experience any of the adverse effects listed above.

If you experience any adverse effects, consult your doctor or pharmacist. To prevent these symptoms, your doctor may prescribe an additional dose of oral corticosteroids during that time (such as prednisolone).

If you have any other questions about the use of this medicine, ask your doctor, nurse, or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. To reduce the occurrence of adverse effects, your doctor will prescribe the lowest dose of Plusvent that controls your asthma.

Allergic reactions: you may notice that your breathing suddenly worsens immediately after using Plusvent. You may experience wheezing, coughing, or shortness of breath. You may also notice itching, rash (urticaria), and swelling (usually of the face, lips, tongue, or throat). You may also suddenly feel that your heart is beating very fast, feel faint, dizzy (which may lead to collapse or loss of consciousness). If you experience any of these effects, or if they occur suddenly after using Plusvent, stop using Plusvent and contact your doctor immediately. Allergic reactions to Plusvent are uncommon (affecting fewer than 1 in 100 people).

Other adverse effects listed below:

Very common (may affect more than 1 in 10 people)

• Headache, which usually improves with continued treatment.
• Increased incidence of colds has been reported in patients with COPD.

Common (may affect less than 1 in 10 people)

• Oral and throat candidiasis (itching, yellow-cream colored sores). Also tongue pain, hoarseness, and throat irritation. Rinsing your mouth with water and spitting it out and/or brushing your teeth immediately after each dose of medication may help. For treatment of candidiasis, your doctor may prescribe antifungal medication (to treat fungal infections).
• Joint pain, swelling, and muscle pain.
• Muscle cramps.

The following adverse effects have been reported in patients with Chronic Obstructive Pulmonary Disease (COPD):

• Pneumonia and bronchitis (lung infection). Inform your doctor if you notice any of the following symptoms: increased sputum production, change in sputum color, fever, chills, increased cough, or increased breathing difficulty.
• Bruising and fractures.
• Sinus inflammation (feeling of pressure or congestion in the nose, cheeks, and behind the eyes, sometimes with pulsating pain).
• Decreased blood potassium levels (you may feel irregular heartbeats, muscle weakness, cramps).

Uncommon (may affect less than 1 in 100 people)

• Increased blood sugar (glucose) levels (hyperglycemia). If you have diabetes, your blood sugar levels will need to be monitored more frequently, and your usual diabetic treatment may need to be adjusted if necessary.
• Cataracts (clouding of the eye's lens).
• Very fast heart rate (tachycardia).
• Tremors and a fast or irregular heartbeat (palpitations). These adverse effects are usually harmless and decrease with continued treatment.
• Chest pain.
• Feeling of anxiety (occurs mainly in children).
• Sleep disorders.
• Skin rash.
• Allergic skin rash.

Rare (may affect less than 1 in 1,000 people)

• Breathing difficulties or wheezing that worsen immediately after using Plusvent. If this happens, stop using Plusvent. Use your fast-acting "rescue" inhaler to improve your breathing and contact your doctor immediately.

• Plusvent may increase normal production of steroid hormones, particularly if you have been taking high doses for long periods. Effects include:

• Growth retardation in children and adolescents.

• Decreased bone mineral density.

• Glaucoma.

• Weight gain.

• Rounded face (moon face) (Cushing's syndrome).

Your doctor will regularly monitor for any of these adverse effects and ensure you are taking the lowest effective dose of Plusvent to control your asthma.

• Behavioral changes such as hyperactivity and irritability (these effects occur mainly in children).
• Irregular heartbeats or extra heartbeats (arrhythmias). Consult your doctor, but do not stop taking Plusvent unless your doctor tells you to.
• Fungal infection of the esophagus (throat), which may cause difficulty swallowing.

Frequency not known, but may also occur:

• Depression or aggression. These effects are more likely to occur in children.
• Blurred vision.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines, www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Plusvent

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label and the carton after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25 °C. Do not refrigerate or freeze.

As with most pressurized inhalers, the therapeutic effect of the medicine may decrease when the cartridge is cold.

The cartridge contains a pressurized liquid. Do not expose to temperatures above 50 °C. Protect from direct sunlight. Do not pierce, break, or burn the cartridge, even if it appears to be empty.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Plusvent

• Each metered dose contains: 25 micrograms of salmeterol (as salmeterol xinafoate) and 125 micrograms of fluticasone propionate.
• The other component is a propellant: norflurane (HFA 134a).

This medicine contains fluorinated greenhouse gases.

Each inhaler contains 12 g of HFC-134a (also known as norflurane or HFA 134a), equivalent to 0.0172 tonnes of CO2 (global warming potential GWP = 1,430).

Nature of the product and pack contents

• Plusvent Inhaler is presented as a pressurized container with a dose counter, which releases the medicine as an inhalation suspension to be breathed in through the mouth into the lungs.

• The cartridge contains a white to off-white inhalation suspension.

• The cartridges are housed in a plastic device incorporating a mouthpiece and a mouthpiece cover.

• The devices are packaged in packs containing 1 inhaler.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

GlaxoSmithKline, S.A.

P.T.M. C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

[email protected]

Manufacturer:

Glaxo Wellcome, S.A.

Avenida de Extremadura, 3 - 09400 Aranda de Duero (Burgos), Spain

or

Glaxo Wellcome Production

Zone Industrielle No.2, 23 Rue Lavoisier, La Madeleine, 27000 Evreux, France

Tel: +33 2 3223 5500; Fax: +33 2 3223 5558

or

Aspen Bad Oldesloe GmbH

Industriestrasse 32-36, D-23843 Bad Oldesloe, Germany.

Date of the most recent revision of this leaflet: 01/2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/